Rapid control of severe bleeding at wound sites is of critical importance in saving lives. Blood loss due to uncontrolled hemorrhage is a major contribution to combat and civilian trauma death before reaching definitive care such as a hospital. Improvements in the ability to control heavy bleeding in the pre-hospital will vastly improve the survival outcomes of trauma. Severe wounds can often be inflicted in remote areas or in situations, such as on a battlefield, where adequate medical assistance is not immediately available. In these instances, it is important to stop bleeding long enough to allow the injured patient (person or animal) to receive medical attention.
Several approaches to date have been used to rapidly stop bleeding in a pre-hospital setting. The most common approach is to provide manual pressure to compress the damaged blood vessel for an indefinite period of time until bleeding stops or transport to definitive care. This is quite difficult not only because of the high blood flow under pressure from a severe wound such as from an artery, but also because it requires knowledge of anatomy to locate the exact site of bleeding and the location where manual pressure will staunch blood flow (the vessel may be deep or the vessel may have retracted). Unless the patient is able to provide self-treatment, manual pressure can be considered to be impractical in many emergency situations due to the need of having one skilled person remain close to the patient to exert continuous pressure, which prevents the care provider from performing other critical life saving functions. Furthermore, heavy direct compression may aggravate damage to other wounded tissues such as fractures, and is inconvenient to apply over irregularly shaped or sensitive body parts. With this approach, it can take a long time to form a stable clot at the injured vessel due to high blood volumes, even when pressed firmly
The gold standard in a hospital is the use of sutures, staples, cautery, tissue glues and adhesives by surgical personnel. Appropriate in a hospital setting, these are generally unfit for use in the field. The disadvantage of these closure methods in a pre-hospital setting is that they are required to be performed by an expert in a controlled environment, and take a significant length of time to apply. By example, cyanoacrylate glue's inability to bind to wet surfaces make topical adhesives of this nature inappropriate for use managing arterial bleeding in the pre-hospital. Severe wounds can often be inflicted in remote areas or in situations, such as in a rural setting, where adequate medical assistance is not immediately available. In these instances, it is important to stop bleeding, even in less severe wounds, long enough to allow the injured person (or animal) to receive definitive care at a site such as a hospital.
An alternative to manual pressure is the use of a tourniquet. While utilization of strap style tourniquets have been widely accepted for military field care for centuries, these devices present a number of disadvantages. They must be applied with sufficient constricting force to cause ischemia distal of the site of application. The induced ischemia is both exceedingly painful to the victim and is a common cause of soft tissue and neurological damage to these body parts if left on too long. Tourniquets are slow and difficult to maneuver and place around the extremity. They are limited in its application by how proximal they can be placed on a limb and do not address major junctional bleeding in the groin or axilla (where larger blood vessels run) or other areas of the body (trunk, neck, scalp, etc).
Packing wounds with conventional field dressings have been used for centuries by military and civilian trauma personnel to slow or stop bleeding. Pressure on the wound immediately at the point of injury with pressure dressings and/or packed field dressings can minimize bleeding by distributing pressure evenly over the wound to achieve hemostasis, as well as by decreasing dead space into which blood can accumulate. Multilayered woven and non-woven fabric or all-purpose wound pads, such as gauze pads of various forms of cotton and other cellulose-type material, absorb significant volumes of blood, and act like a sponge. Although these materials have been shown to be the standard of care, they can be slow to unroll and apply when it is unsafe to do so (e.g. dangerous situations such as when under fire); it is difficult to unroll these materials and pack the wound while maintaining constant manual pressure directly on the vessel since the changing of hands is necessary for unrolling and insertion of each length of bandage into the wound; and these materials do not accelerate the patient's ability to clot beyond the natural clotting mechanism.
As a result, there is an increased tendency for absorbent dressings to become saturated with blood due to unstemmed bleeding. It takes anatomical knowledge to know where to pack the dressings and where to hold pressure onto the vessel. It takes significant time to administer, and are cumbersome in rolls or z-folds requiring a technical knowledge to maintain as constant a pressure as possible on the bleeding vessel.
Additionally, or alternatively, several blood clotting materials are generally known, and are typically in the form of a powder or a fine particulate in which the surface area of the material concentrates clotting factors and leads to hemostasis. Undesirable side effects can occur, as the powders can produce an exothermic reaction upon the application of the material to blood. Oftentimes excess material is unnecessarily poured onto a wound, which can exacerbate the exothermic effects. Depending upon the specific attributes of the material, the resulting exothermia may be sufficient to cause discomfort to or even burn the patient; they can also lead to migration of the powder into the vasculature risking clots/emboli away from the wound site.
To avoid the previous disadvantages, hemostatic dressings have become a method of choice, for insertion into wounds to accelerate the clotting process in situ. By dispersing an adsorbed biocompatible polymer throughout the dressing, the dressing acts as a scaffold to initiate clotting and increase clot adhesion to bandage fiber surfaces at the wound site. Several hemostatic dressings have been developed that accelerate the production of a stable clot through the clotting cascade. One example includes dressings that contain a high concentration of human clotting factors. Another example includes gauze bandages (wound in a roll or cut into sheets) impregnated with mineral agents causing water absorption from the blood to the mineral to concentrate clotting factors. Another example includes gauze bandages (wound in a roll or cut into sheets) impregnated with thrombogenic polysaccharide polymer capable of attracting negatively charged blood cells to the bandage to inducing clotting.
Hemostatic dressings have several disadvantages. First is cost; many of these agents are proteins in the “clotting chain,” such as, fibrinogen, thrombin, Factor VIII and the like. The cost of products made from these products are very high. Second, certain bandages can be of limited use in wet conditions (e.g. clays), since once the bandage gets wet, the active ingredient is unable to concentrate clotting factors, thereby reducing the clotting potential. Third, such dressings are slow to unroll and apply when it is unsafe to do so (e.g. dangerous situations such as when under fire); difficult to unroll and pack the wound while maintaining constant manual pressure directly on the vessel since the changing of hands is necessary for unrolling and insertion of each length of bandage into the wound. Finally, lack of flexibility makes certain bandages difficult to press into wounds without crumbling or breaking.
What is required is a device designed for use in a field environment that can be applied immediately after wounding. A device that addresses these critical aspects of injury care and that will have significant impact on acute events as well as provide an improved outcome late into the time course of treatment and recovery is necessary. It would therefore be advantageous to provide a means of combining the advantages of applying a hemostatic dressing with the simplicity of applying traditional manual pressure via a glove to the wound to reduce blood loss.
Gloves come in many varieties; each designed to protect a person's hand from some sort of hazard without overly impairing the person's manual dexterity. For example, latex gloves protect health care providers such as combat medics and EMT personnel from external contamination while allowing them to handle small, delicate surgical tools, and also prevent the patient from being contaminated by microorganisms on the hands of the health care provider.
Beyond infection control, there are currently no gloves in use that are used/worn by medical personnel to treat patients directly. Bandages that are used by caregivers tend to be in the form of rolls or sheets of woven or non-woven fabric. Gloves that are worn by the caregiver act as a barrier for protection of the caregiver, not for the treatment of the patient by the caregiver.
Bandage gloves are known in the art, and are primarily used for treatment of fingers and hands that can suffer a variety of ailments and injuries such as blisters, arthritis, hand burns, and the like. Examples of such are cloth-like wraps and finger sleeves that have been developed to be placed around an ailing joint to provide warmth and support.
In U.S. Pat. No. 7,767,874 issued to Kellogg et al., a medical glove is provided for removal of excess fluids from body tissue and is particularly useful to treat soft tissue inflammation, damage, edema and/or lymphedema.
In U.S. Pat. No. 5,701,918 issued to Jiraki, provides a glove used in endotracheal intubations having one or more finger extension members attached to and extending outwardly from fingertip portions of one or more finger covers thereof.
In U.S. Pat. No. 5,614,202 issued to DeFina, a moisturizing glove is disclosed in which a middle layer saturated with lotion, an exterior layer of non-porous material, and an inner layer having multiple pores, creates a cavity for receiving and enveloping a hand.
In U.S. Pat. No. 4,853,978 issued to Stockum, an antimicrobial medical glove with an inner coating containing a slow release antimicrobial agent sufficient to maintain an essentially bacteria-free and fungus-free environment within a donned glove.
In U.S. Pat. No. 7,230,153 issued to Flick, a silver bandage (e.g. Silverlon) is formed into a glove and is applied to protect and treat hand burns/wounds from infection.
However, the art fails to describe or suggest a use of gloves to provide external hemostasis treatment, wherein the gloves are worn by the caregiver to treat or provide therapeutic needs. What is desirable is a method to reduce blood loss during/after trauma that mimics the action of manual pressure applied by a first responder, but also mimics the last step of the physiological coagulation mechanism through the use of an adsorbed hemostatic agent to stop bleeding. Furthermore, a device designed for use in a field environment that can be applied immediately to a wound to stop bleeding is desirable.